A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
|ClinicalTrials.gov Identifier: NCT00980876|
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Otitis Externa||Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone||Phase 3|
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Active Comparator: Cipro HC
Drug: Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Experimental: Ciprofloxacin HCl and Hydrocortisone
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Other Name: Otociriax
- Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]
- Identification of possible side effects [ Time Frame: 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980876
|Campinas, São Paulo, Brazil, 13087-000|
|Principal Investigator:||Agricio N. Crespo, Phd||Clínica Quiron|